Efficacy and Safety of Hemorrane Plus Versus Hemorrane and Versus Placebo in Patients With Uncomplicated Haemorrhoids

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a Multicentre, double-blind, randomised clinical trial to evaluate and compare the efficacy and safety of Hemorrane Plus (Hemorrane® + benzocaine) with Hemorrane® and with placebo in patients with uncomplicated haemorrhoids.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Faes Farma, S.A.
• Collaborator: Dynamic Science S.L.

Criteria

Inclusion Criteria:

1. Over 18s and both sexes.

2. Voluntary signing of informed consent.

3. Diagnosis of uncomplicated haemorrhoids: grade I or II non-thrombosed external, mixed, or internal haemorrhoids.

4. VAS of pain ≥ 5 points.

5. VAS of pruritus and stinging/burning ≥ 5 points (for each one).

6. Commitment to comply with the hygienic-dietary measures established for the general management of haemorrhoids.

7. Negative urine pregnancy test (women of childbearing age, if applicable).

8. Patients with adequate understanding of the study and ability to perform the procedures independently.

Exclusion Criteria:

1. History of hypersensitivity to any of the active ingredients or components of the investigational products, as well as hypersensitivity to other local anaesthetics derived from para-aminobenzoic acid (PABA), parabens, or paraphenylenediamine (for example, hair dyes, henna tattoos).

2. Use of topical haemorrhoid medications or other topical agents for the anorectal area less than 48 hours before the start of the study (Visit 1, day 1).

3. Haemorrhoidal surgery that is scheduled between Visit 1 (day 1) and the follow-up visit Visit 3 (day 15±2).

4. Diagnosis of grade III or IV thrombosed external or internal haemorrhoids.

5. Medical history of anaemia, and/or current diagnosis of cardiac or pulmonary disease, shock, sepsis, acidosis, or genetic predisposition (NADH-cytochrome b5 reductase deficiency, glucose-6-phosphate dehydrogenase deficiency, and haemoglobin M disease); that include risk factors for methemoglobinemia.

6. Documented diagnosis of active tuberculosis.

7. Active bleeding haemorrhoids.

8. Presence of pain, stinging/burning, pruritus, anorectal bleeding or rectal bleeding for causes other than haemorrhoidal disease.

9. Presence of bacterial, viral, and/or fungal infections in the perianal area.

10. History of pancreatic pathology that may require performance of a bentiromide diagnostic test.

11. Use of any of the prohibited concomitant medications (sulfonamides, cholinesterase inhibitors, ester or prilocaine-type local anaesthetics, sodium nitrite, neurotoxic insecticides (topical malathion), aminosalicylic acid, suxamethonium, antiarrhythmics, monoamine oxidase inhibitors, tricyclic antidepressants, and PABA derivatives) less than one week prior to the start of the study (Visit 1, Day 1), or throughout the study.

12. Use of any hair dye, including those containing paraphenylene-diamine during the study, from Visit 1 (Day 1) to the follow-up Visit 3 (Day 15 ± 2).

13. Any other circumstance considered by the investigator to prevent adequate follow-up and/or adequate evolution of the response to the study treatments.

14. Pregnant women, those planning an upcoming pregnancy or breast-feeding.

15. Women of childbearing age who do not agree to take the pregnancy test and use valid contraceptive methods during the study and until the end of the use of the investigational treatment. The following are considered valid contraceptive methods: combined hormonal oral, intravaginal or transdermal contraceptives (oestrogen and progesterone), oral, injectable or implantable progesterone-based hormonal contraceptives, intrauterine device (IUD), hormone-releasing intrauterine device, bilateral tubal occlusion, vasectomised partner (as long as they are the only sexual partner of the participating patient and that the success of the intervention has been medically confirmed), or sexual abstinence (abstaining from heterosexual intercourse during the treatment period). The investigator is responsible for determining whether the patient has an appropriate contraceptive method for her participation in the study.

16. Fertile men who use condoms or have had a vasectomy (as long as the success of the intervention has been medically confirmed), or who practise abstinence (abstinence from heterosexual sexual relationships during the treatment period). The investigator is responsible for determining whether the patient has an appropriate contraceptive method for their participation in the study.

17. Patients who have had active cancer in the last five years.

18. Patients who have received an investigational drug (including vaccines) or who have used an invasive medical device in the last 30 days prior to the start of the screening phase or who are currently participating in another clinical trial.

19. Patients who have a family or professional relationship with the research team participating in the clinical study.